This comment is being made in regards to the Notice of Intended Regulatory Action posted regarding changes to VAC 18VAC110-20-10 et seq. Specifically as outlined, the proposed update to 18VAC110-20-240 “Clarifying in subsection C that chart orders used in long term care facilities must include a quantity or duration of treatment.” Currently Virginia regulations do not specifically require a quantity on any prescription regardless of it being considered a “Chart Order”. The Board has already addressed this issue in Guidance Document 110-35 “While Virginia law does not specifically require that quantity be included on a prescription, written prescriptions must include some direction related to quantity to be dispensed, or authorized duration of the order by which the pharmacist can calculate the authorized quantity using directions for use and duration.  Federal regulations require that quantity be indicated on prescriptions for Schedule II-V controlled substances.” Therefore, Remedi SeniorCare does not feel the proposed changes referenced above are necessary. 

This comment is being made regarding changes to 18VAC110-20-240 subsection C clarifying that chart order used in long term care facilities must include a quantity or duration of therapy.  As a general rule, the current pharmacy practice for the skilled nursing setting uses chart orders in the form of 1) admission order/MD Plan of Care, or 2) individual chart orders (verbal orders). Most often the nurse contacts the Physician verbally to receive admission orders.

When the pharmacy dispenses the medications, the qty is generally driven by the payor source; shortened days supply for Medicare Part A Skilled residents and a full month supply for Medicare Part D or third party payer residents.  Continual clinical oversight for medications is routinely occuring in the skilled facility settings.  The skilled facility resident has licensed nursees monitoring the patients and there is a Consultant RPh reviewing medications monthly.  The Physician also performs routine reviews through the recertification process (which could be monthly, every 3 or every 6 months) which are sent to the pharmacy with the physician signature once he has completed the review.  The medication order is considered an active order until the pharmacy receives an order to modify or discontinue the order, or the patient is discharged from the LTC setting.

If this revision is adopted, admission orders received in the pharmacy without a qty or duration stipulated, will result in a delay of processing the medications until the requirements are met.  The same would be true for ongoing orders or if new or changed orders were sent to the pharmcy without requirements.  This has the potential to significantly delay therapy to residents, whom may have just been discharged from the hospital.  This not only has the potential for significant harm to the patients, but it also has implications for the facility in regards to Federal CMS regulations specifically the following Federal Tags:  F425 (Medication Availability is a recurring issues), F332 (Charting omissions/Med Errors per documetation/audit).  This may also effect the CMS reimbursement and Five-Star Quality program ratings for the facility.

I would request that the board continue to allow Long Term Care pharmacies the use of chart orders without the requirement of quantity or duration of therapy, like hospitals and hospice programs, whom we are currently not facing this change.  If you have any additional questions, please do not hesitate to contact me.

Please accept these comments to the NOIRA stage for the periodic review of pharmacy regulations on behalf of the Virginia Health Care Association-Virginia Center for Assisted Living (VHCA-VCAL), our members’ 30,000 employees, and the 29,000 residents served in our over 280 nursing centers and assisted living facilities. VHCA-VCAL is proud of our role as the Commonwealth’s largest association representing long term care. Our strength, effectiveness, and integrity are significantly enhanced by the diversity of our membership, which includes proprietary, non-profit, and government-operated facilities dedicated to providing the highest quality of care.

As this is only a NOIRA, it is difficult to interpret precisely what the Board intends to change.  However, VHCA-VCAL wants to express our general concern that any changes made to 18VAC110-20-240 do not diminish the fact that chart orders remain a valid prescribing method and that regulatory changes do not obstruct the availability/timeliness of medications nor staff resources for direct clinical care of nursing facility residents and patients.  As you are aware, regulations already require periodic order review for nursing facility residents which reconfirm any continued need for medication(s).

Thank you for the opportunity to comment.  Please direct any questions to Steve Ford, SVP, Policy and Reimbursement, at steve.ford@vhca.org  or (804) 212-1695.

To:  Members and staff of the Virginia Board of Pharmacy

From:  H. Otto Wachsmann, Jr

Subject:  Comment period for proposed regulatory changes.

Date:  August 10, 2016

At this time I would like to express some concerns with the background document I received as a member of the Virginia Pharmacists Association.  I regret my comments are at the very end of the comment period however my scheduled vacation and an inability to discuss with the document further with VPhA as their telephone lines were impacted by a storm, I am just now able to provide some hastily prepared thoughts on the document.

In reading the document, I find it is difficult to respond.  While it provides subject material under consideration, it is difficult for me to have a full understanding on which direction many of these proposals are going.

An area that I initially agreed with was siting the CDC vaccine storage recommendations as the new guidelines for pharmacy refrigerators.  I have googled CDC Vaccine Storage and discovered a CDC web page which provided various discussions on the subject but wasn’t necessarily clear.  For example, it discussed how dorm refrigeration units were less than ideal, but didn’t exclude their use except for the freezer compartment.  It discussed advantages and disadvantages of traditional household refrigerators vs especially made units but didn’t necessarily exclude either one.  When discussing certified recording thermometers I wasn’t certain if there was a specific certification.  In attempting to conduct an internet search for these devices, I saw prices ranging from $800.00 to $1800.00 for the thermometer.  I am aware of one doctor’s office that recent purchased a specialty refrigeration that cost thousands of dollars.  I question with today’s reimbursements how a small business such as a family owned pharmacy might be able to purchase something of this magnitude without adequate notice.  It is also possible that I may have read a CDC recommendation/guideline page that was different than what the Board of Pharmacy is referencing.  I also question the validity of using vaccine storage requirements and how they may or may not relate to a pharmacy such as mine that does not store vaccines.  Then there is the question if we would need to have a complaint freezer if we do not stock zostavax? 

In reading the section on the physical barrier for the pharmacy department and the front door, I am hopeful this will not require a complete barrier for the pharmacy floor to ceiling in the event the pharmacy department which is already secured and separately alarmed is only open when the rest of the building is open.  The cost associated with constructing these barriers will be burdensome for family owned pharmacies.  I anticipate this remodel will also require the pharmacy to pay for a re-inspection which further creates a financial burden. 

Regarding the landline security system.  This appears to be going backwards from the Board of Pharmacy requiring cell phone systems.  I wonder how may alarm companies deactivated the old hard line phone system when pharmacies were required to install cell phone systems a few years ago.  For pharmacies that fall into this category, this will require these small businesses to pay to have the alarm companies come back into the pharmacy to reattach the landline.  I expect since this would be a change to the security system, will this not also require the pharmacy owner to have the pharmacy department re-inspected at an additional fee which may well be two inspections and two fees for those who will not be able to coordinate the alarm company at the same time period as the contractor installing the security barrier.  Has the Board of Pharmacy seen a substantial number of cases where these items were an issue?  My experience has been the existing alarm systems work effectively but the police response times cannot keep up with the professional burglars committing the crimes.  Making it too difficult to gain access to a pharmacy after hours is also likely to create a more dangerous situation where the criminals increase the amount of armed robberies occur.  This will results in pharmacy staff and our patients being placed in harms way.

I do not wish to complain about areas in which the Board of Pharmacy promotes to increase patient safety.  That is certainly an important and complex task.  I only wish to provide the perspective of a practicing community pharmacist of some unintended consequences that some of these areas may create.  If I might suggest, it may be helpful to provide some discussion in the Board’s quarterly newletter for additional thoughts and suggestions while providing a better understanding of the issues for practicing pharmacists.  It's quickly becoming quite impossible to keep up with all the state/federal/PBM requirement changes that are going which practitioners are forced to keep up with.  Add to that we are doing these at our expense in a market where stores are closing due to reimbursement issues.  There is less and less time/resources left to actually take care of the patient.

Thanks

Otto Wachsmann

CVS Health appreciates the opportunity to submit comments regarding the proposed Notice of Intended Regulatory Action (NIORA) regarding 18VAC110-20, Regulations Governing the Practice of Pharmacy. The goal of this communication is to provide the Board of Pharmacy (the “Board”) with additional information regarding 18VAC110-20-240 and 18VAC110-20-280 for consideration and incorporation into the final proposal.

Comments:

18VAC110-20-240(C), Manner of maintaining records, prescriptions, inventory records. The Board proposes to add language to clarify subsection (C) that chart orders used in long term care facilities must include a quantity or duration of treatment.

CVS Health recommends the proposed change to 18VAC110-20-240(C) be removed from the proposal to afford the pharmacist the opportunity to continue leveraging good professional judgment as well as the guidance noted in 110-35. Pursuant to the Virginia Board of Pharmacy Guidance Documents 110-35, a chart order should contain directions for use as it relates to the quantity to be dispensed or authorized duration of therapy that the pharmacist can reference in calculating the quantity of medication to be dispensed to the patient. CVS Health believes that this guidance coupled with professional judgment provides pharmacists the best opportunity to serve the elderly population residing in long-term care facilities.

18VAC110-20-280(A)(4)(C), Transmission of a prescription order by facsimile machine. The Board is considering whether there is value in the allowance for residents of long term care facilities and provider pharmacies or if it should be removed.

CVS Health strongly opposes any consideration which would remove the ability for practitioners’ authorized agents to transmit a written prescription from a long-term care facility to a pharmacy provider. Transmission of prescription information by a practitioner’s authorized agent is a long-standing and commonly accepted pharmacy practice and legal principle recognized by the healthcare industry.

The current rule language in 18VAC110-20-280(A)(4)(C) is critical for long-term care facilities to successfully transmit chart orders to provider pharmacies and promotes the most expeditious dispensing and medication delivery model for the facility. The majority of long term care facilities in the state of Virginia still primarily rely on facsimile because more advanced technological solutions may be unattainable due to cost, available resources, IT integration challenges, or other operational barriers. Placing further restriction on the manner in which long term care facilities transmit prescription medication orders will create a significant burden on long term care facility providers, practitioners, and pharmacies.  Removal of the facsimile transmission process by practitioners’ authorized agents in the long-term care facility may lead to unintended consequences such as delays in processing chart orders, delays in medication administration, and jeopardize timely initiation of drug therapy.

As a leader in the long term care pharmacy industry and an advocate for increased patient access to prescription medication, CVS Health recommends the Board reconsider the proposal to 18VAC110-20-280(C) and allow the current language to remain as written.

In closing, CVS Health appreciates the opportunity to provide these comments to the Board of Pharmacy for their review and consideration regarding this proposal and look forward to a favorable outcome for the patients of the Commonwealth of Virginia.

Sincerely,

Bill Irvin, R.Ph.

Director, Pharmacy Regulatory Affairs

CVS Health

13 Commerce Avenue

Londonderry, NH 03053

(603) 339-7846

William.irvin@omnicare.com